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Bihar Family Health Initiative (Ananya)

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ClinicalTrials.gov Identifier: NCT02726230
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : April 1, 2016
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Anita Raj, University of California, San Diego

Brief Summary:
Ananya was funded by BMGF to reduce maternal, newborn, and child mortality; fertility; and child undernutrition in Bihar, India. Ananya involved multi-level interventions designed to build front line health worker (FLW) capacities and reach to communities and households, as well as to strengthen public health facilities and quality of care to increase maternal and neonatal care and health behaviors, and thus survival. From 2012 to 2014, eight focal districts in western and central Bihar.received Ananya, while 30 districts did not. Data were collected from mothers of infants 0-11 months at baseline and mothers of infants 0-23 months at 2 year follow-up, from comparable public health blocks in Ananya and Control districts to assess Ananya effects on quality and quantity of FLW home visits, postnatal health behaviors, and among older infants/toddlers, complementary feeding and vaccination. Difference in difference analyses were used to assess Ananya outcome effects in this quasi experimental study.

Condition or disease Intervention/treatment Phase
Maternal and Child Health Behavioral: Ananya Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27633 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Bihar Family Health Initiative (Ananya)
Study Start Date : January 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ananya Intervention
  1. Strengthen enumeration and mapping of areas to ensure reach of front line workers (FLWs: auxiliary nurse midwives- ANMs; community health workers- ASHAs; anganwadi workers- AWWs).
  2. Convene monthly FLW meetings to build skills and get trained in job kits to increase the quantity and quality of household visits.
  3. Train FLWs on communication skills and use of mobile kunji, a job-aid tool, to improve FLWs' communication with households.
  4. A mass media campaign inclusive of street theatre, tv and radio, and a mobile van.
  5. Community mobilization linking mass media efforts with self-help groups.
  6. Quality improvement activities at public health facilities.
  7. Facility-based skills training to staff delivering infants to improve quality of care
Behavioral: Ananya
The Ananya program was developed and implemented via a partnership of the Bill and Melinda Gates Foundation and the Government of Bihar as a means of improving reproductive, maternal, newborn and child health (RMNCH) outcomes in the state, in particular focusing on improving health behaviors and service utilization in the final trimester of pregnancy and early postpartum period. Ananya was designed as a series of supply- and demand-side efforts to improve health. Efforts were focused on strengthening outreach services in quantity and quality, improving quality of facility services, and mobilizing communities to improve health behaviors. The Ananya program included training, mobilizing, and monitoring of government frontline health workers (FLWs, including anganwadi workers- AWWS, auxiliary nurse midwives- ANMs, and community health workers-ASHAs) to increase quantity and quality of home visits for RMNH screenings and services, and media messages to increase demand for services.

No Intervention: Control Condition
standard of care public health services in India



Primary Outcome Measures :
  1. Receipt of two or more home visits from an FLW in the final trimester of pregnancy, using maternal survey response [ Time Frame: 2 year follow up ]
    Assessed via self-report from representative sample of mothers of children aged 0-11 months; item created for Ananya Survey

  2. Receipt of any postnatal home visits from an FLW (in the first 24 hours at home after delivery and in first month following delivery), using maternal survey response [ Time Frame: 2-year follow-up ]
    Assessed via self-report from representative sample of mothers of children aged 0-11 months; items created for Ananya Survey

  3. Postnatal care behaviors (4 outcomes)- clean cord care, KMC, delayed bath, initiation of breastfeeding), reported by mothers [ Time Frame: 2 year follow-up ]
    Postnatal care practices [Nothing applied to cord or umbilicus; Health worker placed child unclothed on mother's chest/abdomen in skin-to-skin contact; First bath delayed by two or more days; Breastfed child within one hour of birth] assessed via self-report using a single item for each behavior from representative sample of mothers of children aged 0-11 months; items from demographic and health surveys

  4. Any complementary feeding of solid or semisolid food for infants aged 6-11 months, using maternal survey response [ Time Frame: 2 year follow-up ]
    a survey item was used to assesse complementary feeding of infants as reported by mothers of infants aged 0-11 months; items taken from the Demographic and Health Survey

  5. Immunizations (4 outcomes)- receipt of DBT1 and DBT3 for infants 6-11 mo; receipt of DPT3 and measles vaccine for children 12-23 months, using immunization cards or maternal self report if not card [ Time Frame: 2 year follow-up ]
    data from immunization cards or from self-reports when women did not have cards; approximately 50-60% of participants did not have immunization cards



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mothers of infants 0-23 months residing in the catchment area of the subcenters (public health facilities) included in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726230


Sponsors and Collaborators
University of California, San Diego
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Yamini Atmavilas Bill and Melinda Gates Foundattion
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Anita Raj, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02726230    
Other Study ID Numbers: BMGF#22539
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from this study are public and available from the Bill and Melinda Gates Foundation